WHO ( 2020 ) says that data indicate that COVID-19 infections among healthcare workers are far greater than those in the general population :
“ While health workers represent less
than 3 % of the population in the large majority of countries and
less than 2 % in almost all low- and middle-income countries ,
around 14 % of COVID-19 cases reported to WHO are among healthcare workers .
• when it came to PPE , concluding , “ We found low- to very low-certainty evidence that covering more parts of the body leads to better protection but usually comes at the cost of more difficult donning or doffing and less user comfort , and may therefore even lead to more contamination . More breathable types of PPE may lead to similar contamination but may have greater user satisfaction . Modifications to PPE design , such as tabs to grab , may decrease the risk of contamination . For donning and doffing procedures , following CDC doffing guidance , a one-step glove and gown removal , double-gloving , spoken instructions during doffing , and using glove disinfection may reduce contamination and increase compliance . Face-to-face training in PPE use may reduce errors more than folder-based training . We still need RCTs of training with long-term follow-up . We need simulation studies with more participants to find out which combinations of PPE and which doffing procedure protects best . Consensus on simulation of exposure and assessment of outcome is urgently needed . We also need more real-life evidence . Therefore , the use of PPE of HCW exposed to highly infectious diseases should be registered and the HCW should be prospectively followed for their risk of infection .”
A late-2020 Cochrane Review looking at physical interventions to interrupt or reduce the spread of respiratory viruses , Jefferson , et al . ( 2020 ), concluded , “ The high risk of bias in the trials , variation in outcome measurement , and relatively low compliance with the interventions during the studies hamper drawing firm conclusions and generalizing the findings to the current COVID-19 pandemic . There is uncertainty about the effects of face masks . The low-moderate certainty of the evidence means our confidence in the effect estimate is limited , and that the true effect may be different from the observed estimate of the effect . The pooled results of randomized trials did not show a clear reduction in respiratory viral infection with the use of medical / surgical masks during seasonal influenza . There were no clear differences between the use of medical / surgical masks compared with N95 / P2 respirators in healthcare workers when used in routine care to reduce respiratory viral infection . Hand hygiene is likely to modestly reduce the burden of respiratory illness . Harms associated with physical interventions were under-investigated . There is a need for large , well-designed RCTs addressing the effectiveness of many of these interventions in multiple settings and populations , especially in those most at risk of acute respiratory infections ( ARIs ).”
Acknowledging the need for more PPE-driven research , in late February , the ASTM International issued a new standard for barrier face coverings that it says will help establish minimum design , performance , labeling , and care requirements for reusable barrier face coverings . The standard was developed by ASTM ’ s committee on personal protective clothing and equipment ( F23 ).
The new standard ( F3502 ) is intended to apply to the general public and workers and includes specific requirements for barrier face coverings including design and general construction criteria , particle filtration efficiency levels , sizing and fit testing criteria , labeling instructions , and guidance on cleaning and recommended periods of use .
“ Members of the committee worked together to reach a consensus and address the gap that exists for barrier face coverings that are neither a respirator nor a surgical mask ,” says Kathie Morgan , ASTM International president . “ The standard helps to benchmark products and will inform consumers when selecting face coverings for their intended use .”
Numerous ASTM PPE standards have been recognized internationally by the World Health Organization and in the United States by health agencies such as the Centers for Disease Control and Prevention ( CDC ), National Institute for Occupational Health and Safety ( NIOSH ), and the Food and Drug Administration ( FDA ).
In a recent whitepaper , “ Collaboration to Advance Personal Protective Equipment ( PPE ) Safety , Quality , and Innovation ,” ASTM International identified the current landscape of standards development for PPE , including a summary of a recent workshop on fast-tracking standards development , challenges facing PPE quality and availability , and challenges facing standards development .
There are numerous challenges facing PPE quality and availability , and as the ASTM International whitepaper ( 2021 ) acknowledges , “ The scope and magnitude of the COVID-19 pandemic quickly overwhelmed the PPE supply chain , leading to critical shortages .”
Alleviating these shortages is challenging due to several factors , according to the ASTM International whitepaper ( 2021 ):
● Lack of Standardization , Qualification , and Certification : While robust standards and requirements exist for many types of PPE , there are major gaps related to some high-demand equipment such as cloth face coverings and transparent face shields . This extends to qualification and certification as well .
● Reuse of Single-Use PPE : Another option to address PPE shortages is the reprocessing and reuse of PPE units designed for single use . However , this solution comes with a host of challenges , including lack of tests and methods for washing and sanitizing single-use PPE .
● New Environments and Uses : As PPE finds its way into everyday life , it is being used in new and unexpected ways and environments . For example , electrical workers need to consider the flammability of new face coverings .
Impeding the standards development and adoption process are numerous factors , including :
● Lack of Data : Many needed standards cover new areas that are not yet well understood . For nascent topics such as cloth face mask requirements and alternative manufacturing methods , the industry needs to gather more information from a wider